Defines a method for investigation by the manufacturer of the safety of a medical device, including in vitro diagnostic devices or accessories, by identification of hazards and estimation of the risks associated with the device. Particularly helpful in areas where relevant standards are unavailable or unused. Does not define levels of acceptability, or give detailed guidance on management of risks. Nor does it cover decision-making processes regarding assessing the indications and contra-indications for using a particular device.

NEN EN ISO 14971:2009

NEN EN ISO 14971:2007

ONORM EN 1441:1998 - Identical

DIN EN 1441 (1998-01) - Identical

BS EN 1441:1998 - Identical

SN EN 1441:1998 - Identical

UNE EN 1441:1998 - Identical

NS EN 1441:1998 - Identical

I.S. EN 1441:1998 - Identical

UNI EN 1441:1998 - Identical

SS EN 1441 Ed. 1 (1998) - Identical